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From The Lab Bench to the Clinic

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My urge to leave the lab has taken me all the way to director of the department of clinical affairs at Gen-Probe, Incorporated, a biotechnology company in San Diego, California. Gen-Probe develops and manufactures in vitro diagnostic products for detecting infectious diseases and cancer, based on using gene probes to identify the presence of target nucleic acid sequences.

The World of Clinical Affairs

My work involves the planning and execution of clinical trials to support the licensure by the Food and Drug Administration (FDA) of new products for sale. I manage a staff with scientific backgrounds at the Bachelor's, Master’s, or Ph.D. level in one of the life sciences-chemistry, molecular biology, biology, biochemistry, and so on. I supervise and guide my staff in developing clinical protocols, and in identifying medical institutions and clinics that would be good collaborators with us to evaluate our new products. For many of our products, clinical trials are required by federal law to provide information to FDA before that agency allows marketing of the final product. Once a clinical trial is underway, we conduct monitoring visits to each site to ensure their compliance to the protocol and to ensure that all phases of the trial are going well.



Back in the office, we receive huge amounts of data from the clinical trial sites, we enter it into a computer, and we analyze it, hoping that our product performs adequately to support the medical use we've targeted. At this stage, my clinical staff and its efforts interface closely with the regulatory function in the company to prepare a detailed report for the FDA on the product and the results of the clinical trial. This report is submitted to the FDA for their review and their eventual approval or clearance, at which time the company can begin to market the product.

My job entails meeting with members of my staff to review their progress in each clinical trial project and to troubleshoot any issues or barriers to successful completion of the study. In addition, I meet often with individuals or groups from the research and development groups, regulatory affairs, and marketing to address issues that can impact product development. Our group cannot work in isolation, but must stay in constant contact with the other teams within the company that contribute to product development and design.

My job and its associated activities require a broad range of skills for me to be effective and successful. Key job attributes include good organizational skills, clear communication-both written and verbal-good analytical skills for trouble-shooting and data analysis, and interpersonal skills to deal effectively with a myriad of issues and personalities both within and outside of the company.

In dealing with external institutions to conduct our trials, we confront numerous unexpected issues and, frequently, challenging personalities. To conduct an external study requires working closely with a principal investigator who may be an M.D. or a Ph.D., or possibly the head of a medical department and a leader in a particular field of medicine. This person often is used to being at the top of the totem pole, and is not used to having to respond to outsiders.

In addition to the principal investigator, the study really progresses as a result of the coordinated efforts of his or her staff, which includes research nurses, medical technologists, and so on. All of these individuals need different levels of training in the clinical protocols, along with attention and follow-up from me and my staff if our study is to be completed successfully.

All of this coordination, which is taking place simultaneously at several clinical sites across the country, requires a lot of time on the road over the course of the clinical trial. An even bigger chunk of travel time is spent at scientific meetings focused on specific disease areas in which our products are used, or meeting with the FDA (based outside of Washington, D.C.) to discuss our clinical and regulatory strategy for a new product. All of this travel takes up from 25 to 35% of my work time. While the travel can be grueling, I have some freedom to pick and choose the type conferences I attend. I actually enjoy the chance to step away from the daily grind in the office to gather a new perspective, through exposure to new people and ideas.

My Path to Gen-Probe

So, how did I get here? Was this a concerted, well-planned step in my career or was it serendipity? The first significant experience toward my job today started with my education. I had a strong propensity for science as I entered college and I received encouragement from my father, a chemist, which led to my early decision to major in chemistry. After college, I entered a Ph.D. program in biochemistry at the University Of Arizona School Of Medicine. This institution offered me a good mix of opportunities to satisfy my curiosity about biology and my confirmed love of chemistry. I entered into the first biochemistry class in the history of this institution, which consisted of 15 students. The small class size meant that we each received good instruction and lots of mentoring.

I discovered that those often fuzzy chemical concepts from my undergraduate education now became very clear and I relished doing laboratory research. It was both fun and challenging to have my own research project, to figure out how I could add to the scientific knowledge in the area and perhaps even make a significant impact.

I chose a project requiring the isolation and characterization of a protein in the blood coagulation cascade, based on an earlier project I had done in the Red Cross Research Lab. As is true of most graduate programs, I gained an excellent scientific knowledge of biochemistry, and an analytical and systematic approach to the design and execution of my experiments. An ability to write well in order to publish my findings was expected. In addition, and just as important, this project required a large amount of tenacity and perseverance as 50% or more of my experiments initially did not yield useful results. It seemed easier to disprove my hypothesis than to prove it.

Early in my postgraduate career, I met and married a fellow graduate student, whose focus was analytical chemistry. While the addition of a son to our family was welcome, it was also challenging with both mom and dad in graduate school.

Here again, tenacity and commitment were key. I was more focused and earnest about making both career and family work, and it paid off. We both completed our graduate degrees and our son survived us and the process quite well.

I always knew that I was not destined for a teaching career but instead aimed for an R&D job in industry. After a couple of years of postdoctoral training, I followed my husband to the Chicago area where he had landed a job supervising a small clinical reference laboratory that performed a variety of laboratory tests for doctors' offices and small local hospitals. Once our personal lives were somewhat settled and our son was enrolled in a local school, I joined my husband at the reference laboratory as director of research. Although the working conditions and culture were not focused on research, I found my job stimulating, with a variety of technical and personal challenges.

My job was to develop new laboratory tests in response to requests from our customers. My scientific background and training allowed me to explore the literature for published methods, to develop and validate one of those or to create a new method, to document it in a written procedure to be performed by the medical technologists working in the lab, and to train the lab techs to carry out the tests in a reproducible way.

This last step is where my interpersonal skills were challenged. I discovered that while my wonderful new assays had the potential to generate new revenue for the lab, the existing lab staff was only moderately enthused, at best, about learning these new techniques. Although I'd tried to design methods based on technology and procedures common to other tests currently performed in the lab, some new methodologies were required. I was excited about learning new technology and using new lab equipment, and I was rapidly expanding my scientific experience because each new test was so very different from the last. I discovered to my surprise that the lab staff was not very receptive to learning these new techniques because that meant a change for them. This change required taking time to learn new methods, which added to their work load. The addition of one more test to the lab's menu meant more responsibility for each of them in an already hectic work schedule.

Although I'd been convinced in graduate school that teaching was not my forte, I had to develop clear, concise teaching techniques and I offered lots of reassurance and enthusiasm to encourage the staff to accept and learn these new methods. While I initially thought I was contributing significantly to the organization, the initial reaction of those directly impacted by my work-the lab techs-made me feel that I was detracting from that environment. This experience expanded my technical expertise and taught me vivid lessons in how critical it is to deal effectively with people to gain acceptance for new ideas.

After about a year in this organization, I moved on to a very large pharmaceutical company, Abbott Laboratories, Inc., where I worked as a product development scientist in the Diagnostics Division. This group included scientists with backgrounds in chemistry, biochemistry, and immunology, and a group of engineers who were developing an instrument and chemical reagents for tests that would measure various cardiac, epileptic, and antibiotic drugs in patient serum.

My job was to develop reference methods for these new tests using high performance liquid chromatography (HPLC). As time went by, I began to develop some new tests based on immunoassay technology. Again, I was able to apply my biochemistry and chemistry technical backgrounds to the job. I learned a great deal about organic and analytical chemistry as they are applied to real-world situations.

I also came to realize that I was fortunate to be in the right place at the right time. Everything we worked on came to fruition, either as a marketed product or by adding to our scientific knowledge about the technology and products with which we worked. I was also exposed to marketing and I participated in some road trips to visit customers and introduce them to our products and to do trouble-shooting in their labs. This gave me a close look at the customer. This early exposure was invaluable later when I had a role in recommending to company management new tests and new test features for development.

I also had my first exposure to clinical research. Our development team did not have a clinical department to do the studies and trials required for FDA clearance of our products. Consequently, we did a lot of this work ourselves. I had to identify test sites, train the site staff regarding our products and protocols, and analyze resulting data. I entered the world of computers and statistics, which was both necessary and extremely useful. This activity was very rewarding at the time-it gave me the opportunity to see how the real user handled the product I developed and how that product performed in the real world.

One of the other skills I came to appreciate and develop was the ability to multitask-to handle multiple, unrelated projects without dropping any balls. In this case, the tasks were to run an analytical lab and to develop immunoassays. These are technically very different functions that require different approaches. Also, the first task was a service function that I provided to several other scientists in the development group. This required that I meet their needs on demand while continuing to further my own development projects. As a consequence, I had to learn how to manage stress adequately. Both of these abilities have remained important as my career has progressed.

I was fortunate to have a scientific mentor in the form of my first boss, who still remains a good friend today. He ensured that I had adequate freedom to do my technical work as I saw fit. And even when I was challenged and sought his advice to solve technical problems, he helped me most by not giving me his best answer but by encouraging me to continue my independent pursuit of a solution. My mentor worked closely with the general manager of our project, who later left Abbott and moved to Allied Instrumentation Laboratory in the Boston area.

After 4 years at Abbott I was recruited by Allied as a project manager, overseeing the development of a small instrument and the associated clinical chemistry tests that were to be sold to doctors' office laboratories. This organization, like Abbott, included both chemists and engineers. I had to deal with both instrument and reagent technical development by guiding and motivating a diverse team of individuals.

A merger between our company and Allied Chemical, Inc., brought many months of uncertainty about our long-term fate. We experienced a lot of doubt and fear as to whether we'd have jobs the following year. Our concerns were well-founded-nearly everyone was faced with the need to find another job. Although I was offered a job right away at one of the subsidiary companies, I chose not to stay on the East Coast but instead, to find a job out West where I grew up and where my family lived. The disintegration of the organization in Boston accompanied the disintegration of my marriage, and I now had the freedom to seek the job and locale that suited me.
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